1. ACCREDITATION PROCESS
Role of SANAS and
ACCREDITATION PROCESS

2. Accreditation Act.
No. 19 of 2006: Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006
ACT
To provide for an internationally recognised and effective accreditation and monitoring system for the Republic by establishing SANAS as a juristic person; to recognise SANAS as the only accreditation body in the Republic for the accreditation of conformity assessment and calibration and monitoring of good laboratory practice; and to provide for matters connected therewith.

3. Government Bodies and Regulators
In order to make informed decisions, they must have confidence in the data generated by laboratories carrying out testing, measurement or calibration in these fields
Using an accredited laboratory can help establish and assure this confidence

4. Government Bodies and Regulators

5. Accreditation Facilities
Blood Transfusion Services
Calibration Laboratories
Forensic Laboratories
Legal Metrology
Medical Laboratories
Pharmaceutical
Testing Laboratories
Veterinary
B-BBEE Verification Agencies
Certification Bodies
Inspection Bodies
Proficiency Testing
GLP and GCP

6. What is Accreditation? Accreditation assessment of a facility
“An independent assessment (by experts) on the competence of an organisation and/or individual to perform tests against a schedule of accreditation”
Accreditation confirms technical competence

7. Accreditation Program for BBBEE VA’s
Accreditation of BEE verification agencies is conducted by SANAS on behalf of the dti in terms of the accreditation criteria, and is maintained and enforced by SANAS
Broad-Based Black Economic Empowerment Amendment Act, 2013.
B-BBEE Codes of Good Practice
Verification manual (Government Gazette 31255)
R47and
Sector Codes

8. What makes SANAS Acceptable?
SANAS has to comply with international criteria (including Quality Management criteria) and demonstrate our technical competence with regards to the various sectors that is accredited
Peer evaluation by international teams with relevant expertise
Periodically re-assessed 2-4 years to ensure continued compliance with requirements

9. Accreditation application Process
Application and Submission of the Quality Manual
Document Review
Initial assessment
Clearance of non-conformance
Approvals Committee
Accreditation
Six Month visit
Annual assessment
Re-assessment

10. Application and Submission of the Quality Manual
Review of the application by SANAS to determine the scope and the expertise that will be required
SANAS sending out the acknowledgement letter which also spells out the processes that will follow.
Application and Document Review payment (Invoice valid for 30 days)
The application and Document Review fee (fee structure is on P14)

11. Document Review
Document Review carried out against the ISO/IEC by a SANAS Lead Assessor
Document Review report to be given to the VA after 4 weeks.
VA is given 6 months to work on non-conformances identified during the document review process.
If there are major gaps identified, the laboratory might be required to re-submit its Quality Manual for a second review.

12. Process Non-conformances
Initial Assessement
Process Non-conformances
Initial Assessment is carried out by a full strength team i.e. a team comprised of a Lead Assessor and Technical Assessors/Experts.
The time frame for initial assessment depends on many factors such as:
Availability of the assessment team
SANAS receiving payment from the VA
Readiness of the VA
VA is given a total of 6 months to work on non-conformances identified during the initial assessment.
After submitting the corrective actions, the assessment team has 5 working days to evaluate corrective actions.

13. Process Non-conformances
Approval process
When all the corrective actions have been accepted by the assessment team, the assessment pack will be reviewed by the Approval Advisory Committee (AAC) within a month.
Within two days of the AAC meeting, laboratory will be advised of the accreditation outcome.
If the assessment team’s recommendation has been approved, the laboratory will receive the Certificate and Schedule of Accreditation within 15 working days of the AAC meeting.

14. Six Month visit
Annual Assessment
Re-assessment
The purpose of the visit is to follow-up on any non-conformances raised at the initial assessment and to ensure that the management system is still implemented and functioning properly.
SANAS will check for continuing compliance with accreditation requirements by carrying out surveillance visits at periods not exceeding 24 months
Re-assessment visits will involve a comprehensive re-examination of the VA’s accredited activities

15. Important information
The accreditation process takes at least minimum of 6 months from application to granting of accreditation. Thus, if an application has been submitted in April 2015, the entire process could be concluded by September 2015.
Each stage is preceded by payment by the laboratory
Initial Assessment depends of various factors, namely: Availability of the assessment team; type of expertise required; readiness of the laboratory and payment of the assessment fee.
An application that has not proceeded to the initial assessment stage within 1 year from the date of application will lapse

21. Relationships
DTI
Policy-Makers
End user- Accreditation gives assurance and confidence in the results
SANAS
Ensures competence within accredited facilities
Verification Agency
Certificates and reports issued by the accredited facilities are recognised
Accreditation gives assurance and confidence in the results
End User

22. Questions
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